Esomeprazole Magnesium Granule, Delayed Release
NDC Package 13668-548-94

11-digit billing NDC: 13668054894 · Billing unit: EA · 30 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Esomeprazole Magnesium granules is esomeprazole magnesium for delayed-release oral suspension is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. This formulation utilizes a granule, delayed release delivery system. Marketed by Torrent Pharmaceuticals Limited, this product is identified by NDC 13668-548 and is authorized under FDA application ANDA212652.

Identification & Billing

NDC Package Code
13668-548-94
Package Description
30 GRANULE, DELAYED RELEASE in 1 CARTON
Product Code
13668-548
11-Digit Billing Format
13668054894
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 861568 - esomeprazole 10 MG Granules for Delayed Release Oral Suspension
  • RxCUI: 861568 - esomeprazole 10 MG Granules for Oral Suspension
  • RxCUI: 861568 - esomeprazole 10 MG (equivalent to esomeprazole magnesium 11.1 MG) Granules for Delayed Release Oral Suspension

Clinical Specifications

Proprietary Name
Esomeprazole Magnesium For Delayed-release Oral Suspension
Non-Proprietary Name
Esomeprazole Magnesium
Substance Name
Esomeprazole Magnesium
Dosage Form
Granule, Delayed Release - A small medicinal particle or grain to which an enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ESOMEPRAZOLE MAGNESIUM 10 mg/1
Pharmacologic Class
Usage Information
Esomeprazole magnesium for delayed-release oral suspension is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)].For information about contraindications of amoxicillin and clarithromycin, indicated in combination with esomeprazole magnesium for delayed-release oral suspension for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information.Proton pump inhibitors (PPIs), including esomeprazole magnesium, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].

Regulatory & Marketing

Labeler Name
Torrent Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA212652
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-05-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 13668-548-94 identifies a specific commercial package of 30 granule, delayed release in 1 carton of Esomeprazole Magnesium For Delayed-release Oral Suspension, a human prescription drug labeled by Torrent Pharmaceuticals Limited. This granule, delayed release is formulated for oral use and contains esomeprazole magnesium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Torrent Pharmaceuticals Limited on March 05, 2025. The current certification is valid through December 31, 2027.

How is this Torrent Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13668054894. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
13668-548-94
11-Digit CMS (5-4-2)
13668-0548-94

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.